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This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body.
The study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood.
Part 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given.
Participants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.
CRB-913 is a novel cannabinoid receptor type 1 (CB1) inverse agonist (CB1-IA) that is being developed for once-daily treatment of obesity.
This study will look at how the investigational drug CRB-913 behaves in the body and how it affects body weight.
The study has two parts:
Part 1 will include healthy adult participants. They will receive CRB-913 in tablet form. Researchers will measure how much of the drug enters the bloodstream and how long it stays there.
Part 2 will include participants who will receive one of three different doses of CRB-913 or a placebo (a tablet with no active drug). This part of the study will look at the safety of CRB-913 and its effects on body weight. Researchers will also measure the amount of CRB-913 in the blood.
Part 2 is blinded, which means that participants, study doctors, and the study sponsor will not know who is receiving CRB-913 or placebo.
All participants in Part 2 will take their assigned study tablets for 12 weeks, followed by a 28-day follow-up period after treatment ends.
The information collected in this study will help determine whether CRB-913 is safe, how the body processes it, and whether it may help with weight-related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: PK Lead-in | Experimental | Primary Treatment Period (Day 1): Participants will receive a single dose of CRB-913. Following Part 1 of the study Part 2 will open for recruitment. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
|
| Part 2: CRB-913 low dose | Experimental | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 low dose which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
|
| Part 2: CRB-913 Medium Dose | Experimental | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 starting at low dose for 14 days and increasing to medium dose at day 15 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
|
| Part 2: CRB-913 High Dose | Experimental | Primary Treatment Period (Day 0 - Day 85): Participants will receive CRB-913 starting at low dose for 14 days, increasing to medium dose at day 15 for 14 days and then increased to high dose at day 29 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRB-913 | Drug | Administered QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax | Maximum plasma concentration (Cmax) | 0 to 48 hours |
| Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax | Time to maximum plasma concentration (Tmax) | 0 to 48 hours |
| Part 1: To evaluate the PK of a single dose of CRB-913 - T1/2 | Terminal elimination half-life (T1/2) | 0 to 48 hours |
| Part 2: To evaluate the safety of CRB-913 - TEAE | Incidence and severity of treatment emergent adverse events | Day 1 to 28 days post final dose |
| Part 2: To evaluate the safety of CRB-913 - AESI | Incidence of adverse events of special interest | Day 1 to 28 days post final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: To evaluate the safety of a single dose of CRB-913 - TEAE | Incidence and severity of treatment emergent adverse events | Day 1 to 28 days post final dose |
| Part 2: To evaluate the effect of CRB-913 on weight |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: To evaluate changes in food noise | Mean change from baseline in food noise questionnaire (FNQ) score | Day 1 to 28 days post final dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leela Vrishabhendra, MD | Medpace Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | United States | ||
| Arizona Clinical Trials |
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Part 1 is open label. Part 2 is double blind.
|
| Part 2: Placebo | Placebo Comparator | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 matching placebo which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
|
| Placebo | Drug | Administered QD |
|
Mean change in absolute body weight from baseline to End of Treatment (EOT) compared to placebo
| Day 1 to 28 days post final dose |
| Part 2: To evaluate the PK of CRB-913 - Cmax | Maximum plasma concentration (Cmax) | Day 1 to 28 days post final dose |
| Part 2: To evaluate the PK of CRB-913 - Tmax | Time to maximum plasma concentration (Tmax) | Day 1 to 28 days post final dose |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Prospective Research Innovations | Rancho Cucamonga | California | 91730 | United States |
| Accel Research Sites | DeLand | Florida | 32720 | United States |
| Tampa Bay Medical Research | Largo | Florida | 33761 | United States |
| Quotient Sciences | Miami | Florida | 33126 | United States |
| Louisville Metabolic and Atherosclerosis Research Center | Louisville | Kentucky | 40213 | United States |
| Alliance Clinical | Las Vegas | Nevada | 89109 | United States |
| Neurobehavioral Research | Cedarhurst | New York | 11516 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Lucas Research | Morehead City | North Carolina | 28557 | United States |
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
| Velocity Clinical Research | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research | Dallas | Texas | 75230 | United States |
| Flourish Research | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| D009750 | Nutritional and Metabolic Diseases |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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